The Impact of Dexmedetomidine Nasal Spray on Perioperative Anxiety in Neurosurgical Patients

NCT07801014 | Not Yet Recruiting

• 1 other identifier: 20260828
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial aims to evaluate the effect of preoperative use of dexmedetomidine nasal spray on improving perioperative anxiety levels in patients undergoing elective supratentorial tumor resection.

Conditions

Anxiety; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Difference in scores of the State-Trait Anxiety Inventory-State (STAI-S)

  Difference in scores of the State-Trait Anxiety Inventory-State (STAI-S) from the preoperative baseline (1 day before surgery) to the 5th day after surgery.

  Postoperative 5 day

Study Arms (2)

Dexmedetomidine nasal spray combined with routine perioperative management

ACTIVE COMPARATOR

Patients in this group will receive dexmedetomidine nasal spray in the ward on the night before surgery and on the morning of surgery.The standard dose is 100μg. For subjects older than 60 years or weighing less than 45 kg, the dose is adjusted to 75 μg. Patients also receive the same routine perioperative management as the control group.

Drug: Dexmedetomidine

Routine perioperative management

NO INTERVENTION

Patients in this group do not receive any nasal spray intervention. Patients receive routine perioperative management.

Interventions

Dexmedetomidine DRUG

Patients will receive dexmedetomidine nasal spray in the ward on the night before surgery (before bedtime) and on the morning of surgery (about 1 - 2 hours before anesthesia induction). When administering the drug, the patient should sit upright with the head slightly forward, shake well before use and pre-pray to activate the device. The standard dose is 100μg (2 sprays in each nostril, 4 sprays in total, 25 μg per spray). For subjects older than 60 years or weighing less than 45 kg, the dose is adjusted to 75 μg (a total of 3 sprays, alternately sprayed into both nostrils, for example, 2 sprays in the left nostril and 1 spray in the right nostril, or vice versa).

Dexmedetomidine nasal spray combined with routine perioperative management

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical status I to III
• Scheduled to undergo elective supratentorial tumor resection
• Preoperative STAI-S score \>45
• Obtain written informed consent

You may not qualify if:

• Severe hepatic or renal insufficiency
• Allergy to dexmedetomidine or its excipients
• Severe bradycardia (heart rate \<50 bpm), sick sinus syndrome, or second-/third-degree AV block without pacemaker
• Use of α2-agonists, benzodiazepines, or other sedatives/analgesics within 24 hours preoperatively
• History of alcohol, drug, or psychoactive substance dependence
• Diagnosed or suspected obstructive sleep apnea syndrome
• Nasal anatomical abnormalities, acute rhinitis, epistaxis, or other nasal conditions affecting drug administration
• Pregnancy or lactation
• Communication barriers, psychiatric disorders, or cognitive impairment precluding scale completion
• Visual/hearing impairment or inability to read

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yuming Peng, MD,Ph.D

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Zeng, MD,Ph.D

CONTACT

8610-59976658; fly800727@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief of Department of Anesthesiology

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 2, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

CN (1)